FDA Device recall Z-0750-2022
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagen…
- FDA Device
- Class II
- ongoing
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagen… by Hologic, citing failed stability specifications for reagent kits that may result in false negative test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0750-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-27 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hologic |
| Distribution | US |
Product
Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA
Reason
Failed stability specifications for reagent kits that may result in false negative test results.
Identifiers
| code_info | Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusio…Panther Fusion Extraction Reagent-X - Lot Numbers: 281375 and 291829 Components included within the kit: Panther Fusion Capture Reagent-X (FCR-X) - Lot Numbers: 281330 and 290312 Panther Fusion Enhancer Reagent-X (FER-X) - Lot Numbers281332 and 290331 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0750-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.